Type 2 DiabetesCir-D-BrainNCT06243172
Determining Circadian Metabolic and Behavioural Rhythms in Patients with and Without Type 2 Diabetes
An observational study of Type 2 Diabetes and Circadian Rhythm, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
The goal of the present clinical descriptive study is to characterize and quantify the potential hormonal chronobiological differences between individuals with type 2 diabetes (T2D) and healthy age and weight-matched controls as either circadian aligned or misaligned. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Circadian Rhythm
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic, Steno Diabetes Center Copenhagen out-patient clinic, community sample
Who may be able to join
- Individuals with T2D:
- Informed and written consent.
- Clinically diagnosed diabetes mellitus type 2 for at least 5 years (diagnosed according to criteria of World Health Organization (WHO)).
- HbA1c >53 mmol/mol
- Stable medical treatment for at least 8 weeks.
- Plasma haemoglobin ≥8.00 mmol/L (male) or ≥6.4 mmol/L (female).
Show all 11Show fewer
- Male or female participants aged 50-75 years.
- Healthy matched controls:
- Informed and written consent.
- Normal haemoglobin ≥8.00 mmol/L (male) or ≥6.4 mmol/L (female).
- Male or female participants aged 50-75 years.
Who cannot join
- Body mass index (BMI) <23 kg/m2
- Receipt of any investigational medicinal product within 3 months before screening in this trial.
- Inability to perform neuropsychological tests (e.g., visual impairment or auditory impairment, or language barrier).
- Participants with mental incapacity or language barriers precluding adequate understanding or co-operation or who, in the opinion of the investigator or their general practitioner, should not participate in the trial.
- Prior or contemporary use of any kind of hypnotica within 6 months, former p.n. use of melatonin is judged by the investigator.
- Nightshift-worker.
Show all 20Show fewer
- Known dementia or any other major disorders that in the opinion of the investigator precludes compliance with the protocol, evaluation of the results or represent an unacceptable risk for the participant's safety.
- Diagnosed sleep disorders (e.g., sleep apnoea and narcolepsy).
- Significant history of alcoholism or drug/chemical abuse as per investigator's judgement.
- Severe hypoglycaemic event during the past 6 months requiring medical assistance.
- Diagnosed diabetic retinopathy.
- Severe renal insufficiency defined as estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m2 or any kind of kidney disease that in the opinion of the investigator involves an unnecessary risk for the participants.
- Cardiac problems including any of the following:
- Classified as being in New York Heart Association (NYHA) class III or IV.
- Angina pectoris (chest pain) within the last 6 months.
- Inadequately treated blood pressure at screening defined as repeated resting blood pressure outside the rage 90-150 mmHg for systolic and 50-100 mmHg for diastolic blood pressure.
- Known lung disease that in the opinion of the investigator represents an unacceptable risk for the participant's safety.
- Active or recent (≤ 12 months) malignant disease is judged by the investigator.
- For females only: Pregnancy, breast-feeding status, or intention of becoming pregnant during the trial.
- For healthy matched controls: prediabetes defined as HbA1c between 42-47 mmol/mol
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Copenhagen
Herlev, 2730
Helena Z Wodschow, MD, +45 30313426, helena.zander.wodschow.03@regionh.dk
Jørgen Rungby, MD, DMSc, +45 21686620, joergen.rungby@regionh.dk
About this study
Official title: Determining Circadian Metabolic and Behavioural Rhythms in Patients with and Without Type 2 Diabetes and Identifying the Relation to Hormone and Glucose Fluctuations, and Cognition
The goal of the present clinical descriptive study is to characterize and quantify the potential hormonal chronobiological differences between individuals with type 2 diabetes (T2D) and healthy age and weight-matched controls as either circadian aligned or misaligned. The investigators hypothesize that individuals with T2D have a misaligned and different circadian rhythmicity of circadian biomarkers (melatonin and cortisol) than controls, and that this difference in turn is related to 24h hormonal fluctuations, behaviour, and metabolic-, cardiac-, and cognitive parameters.
Participants will be asked to:
- fill-out a diary on eating and sleeping habits for 30 days
- wear an actigraphy and continuous glucose monitor for 10-14 days
- stay overnight at the research facility, including continuous blood sampling and polysomnography
Read the detailed description
T2D is associated with cognitive dysfunction and an increased risk of developing dementia. This negative effect on cognition is worsened by T2D duration, yet the mechanisms are unknown.
Sleep disturbances increase peripheral insulin resistance, and is associated with the development of T2D, temporarily worsened cognitive function, and the development of cognitive impairment. In turn, T2D is associated with circadian misalignment (a condition where the internal physiological clock is unaligned with the external behavior). A major external signal (also known as zeitgeber) for synchronizing the internal and external clock is sleep in accordance with the day-night cycle.
Determining the circadian rhythm of an individual and whether it is aligned or misaligned is complex and can't be done by one measurement. However, melatonin and cortisol are often used as "circadian biomarkers" due to significant and well-defined circadian rhythm profiles. Another measure of the circadian phase is the timing of melatonin production under dim light conditions (dim light melatonin onset) which is an individual phase marker depending on the persons habitual time of sleep. Most studies focusing on circadian alignment in an everyday setting have used questionnaires, and to our knowledge, no studies have described 24-h circadian oscillations between individuals with T2D and healthy age and weight matched controls. Mapping these potential differences could help explain the pathophysiological mechanisms behind T2D and circadian misalignment.
The Cir-D-Brain study is a clinical descriptive study. The study comprises of an information visit, a screening visit, a midway visit (2 weeks after screening), a 24-h in-hospital day (a day between the midway visit and the final visit), and a final visit (2 weeks after the midway visit). Participants will keep a diary on eating and sleeping habits for all 30 days. At the midway visit, participants will be equipped with an actigraphy and a continuous glucose monitor. At the 24-h in-hospital day, participants will have their blood sampled every third hour for 24 hours to measure their circadian rhythm, every hour from 6 pm till 12 am to map dim light melatonin onset, and at wake-up to map cortisol awakening response. At the 24-h in-hospital day, participants will furthermore have their sleep stages measured by polysomnography. The study will include 30 participants with T2D and 30 age and BMI matched controls.
The specific objectives are:
- To characterize and quantify the hormonal chronobiological differences between individuals with T2D and healthy matched controls measured by circadian biomarkers.
- To relate the findings to 24-h hormonal fluctuations, different patterns in metabolism, behavioural circadian rhythms differences (sleep-wake and eating habits), sleep stages, glycaemic variability, inflammation, heart rate variability, and cognition.
- Conditions
- Type 2 Diabetes, Circadian Rhythm
- Keywords
- Type 2 Diabetes, Circadian Rhythm, Cognition, Sleep
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | Individuals with type 2 diabetes | |
| Controls | Individuals without type 2 diabetes matched on age and body mass index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin oscillations (amplitude, peak, mesor, phase, period length (TAU))
Blood samples
Measured: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Cortisol oscillations (amplitude, peak, mesor, phase, period length (TAU))
Blood samples
Measured: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Secondary outcomes (20)
Dim light melatonin onset
Blood samples (pg/ml)
Measured: 24-hour in-hospital day, blood samples taken every hour from 18:00 until 00:00 (7 timepoints in total)
Phase angle (time between dim light melatonin onset and sleep)
Blood samples
Measured: 24-hour in-hospital day, blood samples taken every hour from 18:00 until 00:00 (7 timepoints in total)
Cortisol awakening response
Blood samples (pg/ml)
Measured: 24-hour in-hospital day, blood samples taken at wake up, and 15-, 30-, and 60-minutes post-wake up
Diary on sleeping habits
Expanded Consensus Sleep Diary (time in bed, time to fall asleep, number of awakenings and durations, time of final awakening, time to get out of bed, total sleep time, sleep quality, daytime sleepiness, number of naps and duration, number and last time of alcohol consumption, number and last time of coffein consumption, use of sleep medicine)
Measured: 30 days
Diary on eating window
The eating window (initiation of first consumption and termination of last consumption of food)
Measured: 30 days
Glycaemic variability
Continuous glucose monitor (amplitude (mmol/L), frequency, and duration of the fluctuation, mean glucose (mmol/L), time in range, time in hyperglycemic and hypoglycemic range, area under the curve)
Measured: 10-14 days
Sleep and waking states
Actrigraph worn on the wrist of the non-dominant hand (acceleration at different times)
Measured: 10-14 days
Heart rate variability (fluctuations in time intervals between adjacent heart beats)
Measured continuously by the polysomnograph (ms)
Measured: 24-hour in-hospital day
Sleep architecture
Polysomnography (minutes and percentages). Sleep stages (N1, N2, N3, rapid eye movement (REM)), total time asleep, sleep latency, REM sleep latency, arousals, awakenings, total sleep efficiency.
Measured: 24-hour in-hospital day
Cognition (verbal memory)
Rey Auditory Verbal Learning Test (RAVLT)
Measured: 24-hour in-hospital day
Cognition (psychomotor speed and executive function)
Trail Making Test (TMT) part A and B ), Symbol Digit Modalities Test (SDMT)
Measured: 24-hour in-hospital day
Cognition (executive function)
WAIS-III Letter-Number Sequencing test, Verbal fluency test (letters S and D)
Measured: 24-hour in-hospital day
Cognition (sustained attention)
Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: 24-hour in-hospital day
Cognition (verbal IQ)
Danish Adult Reading Test (DART) (equivalent to the National Adult Reading Test; NART)
Measured: 24-hour in-hospital day
Insulin oscillations (amplitude, peak, mesor, phase, period length (TAU))
Blood samples.
Measured: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
C-peptide oscillations (amplitude, peak, mesor, phase, period length (TAU))
Blood samples.
Measured: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
TSH oscillations (amplitude, peak, mesor, phase, period length (TAU))
Blood samples.
Measured: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Glucose oscillations (amplitude, peak, mesor, phase, period length (TAU))
Blood samples.
Measured: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Glucagon oscillations (amplitude, peak, mesor, phase, period length (TAU))
Blood samples.
Measured: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Glucagon-like peptide-1 (GLP-1) oscillations (amplitude, peak, mesor, phase, period length (TAU))
Blood samples.
Measured: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Feb 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Sponsor
- Investigators
- Jørgen Rungby, MD, DMSc, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243172
- Sponsor's protocol ID
- H-22014311
- Acronym
- Cir-D-Brain
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Circadian Metabolic and Behavioural Rhythms in Patients with and Without Type 2 Diabetes and Identifying the Relation to Hormone and Glucose Fluctuations, and Cognition
- ClinicalTrials.gov ID
- NCT06243172
- Acronym / sponsor ID
- Cir-D-Brain / H-22014311
- Conditions
- Type 2 Diabetes, Circadian Rhythm
- Keywords
- Type 2 Diabetes, Circadian Rhythm, Cognition, Sleep
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, University Hospital Bispebjerg and Frederiksberg
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the present clinical descriptive study is to characterize and quantify the potential hormonal chronobiological differences between individuals with type 2 diabetes (T2D) and healthy age and weight-matched controls as either circadian aligned or misaligned. The investigators hypothesize that individuals with T2D have a misaligned and different circadian rhythmicity of circadian biomarkers (melatonin and cortisol) than controls, and that this difference in turn is related to 24h hormonal fluctuations, behaviour, and metabolic-, cardiac-, and cognitive parameters.
Participants will be asked to:
- fill-out a diary on eating and sleeping habits for 30 days
- wear an actigraphy and continuous glucose monitor for 10-14 days
- stay overnight at the research facility, including continuous blood sampling and polysomnography
Detailed description
T2D is associated with cognitive dysfunction and an increased risk of developing dementia. This negative effect on cognition is worsened by T2D duration, yet the mechanisms are unknown.
Sleep disturbances increase peripheral insulin resistance, and is associated with the development of T2D, temporarily worsened cognitive function, and the development of cognitive impairment. In turn, T2D is associated with circadian misalignment (a condition where the internal physiological clock is unaligned with the external behavior). A major external signal (also known as zeitgeber) for synchronizing the internal and external clock is sleep in accordance with the day-night cycle.
Determining the circadian rhythm of an individual and whether it is aligned or misaligned is complex and can't be done by one measurement. However, melatonin and cortisol are often used as "circadian biomarkers" due to significant and well-defined circadian rhythm profiles. Another measure of the circadian phase is the timing of melatonin production under dim light conditions (dim light melatonin onset) which is an individual phase marker depending on the persons habitual time of sleep. Most studies focusing on circadian alignment in an everyday setting have used questionnaires, and to our knowledge, no studies have described 24-h circadian oscillations between individuals with T2D and healthy age and weight matched controls. Mapping these potential differences could help explain the pathophysiological mechanisms behind T2D and circadian misalignment.
The Cir-D-Brain study is a clinical descriptive study. The study comprises of an information visit, a screening visit, a midway visit (2 weeks after screening), a 24-h in-hospital day (a day between the midway visit and the final visit), and a final visit (2 weeks after the midway visit). Participants will keep a diary on eating and sleeping habits for all 30 days. At the midway visit, participants will be equipped with an actigraphy and a continuous glucose monitor. At the 24-h in-hospital day, participants will have their blood sampled every third hour for 24 hours to measure their circadian rhythm, every hour from 6 pm till 12 am to map dim light melatonin onset, and at wake-up to map cortisol awakening response. At the 24-h in-hospital day, participants will furthermore have their sleep stages measured by polysomnography. The study will include 30 participants with T2D and 30 age and BMI matched controls.
The specific objectives are:
- To characterize and quantify the hormonal chronobiological differences between individuals with T2D and healthy matched controls measured by circadian biomarkers.
- To relate the findings to 24-h hormonal fluctuations, different patterns in metabolism, behavioural circadian rhythms differences (sleep-wake and eating habits), sleep stages, glycaemic variability, inflammation, heart rate variability, and cognition.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | – | –Individuals with type 2 diabetes |
| Controls | – | –Individuals without type 2 diabetes matched on age and body mass index |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic, Steno Diabetes Center Copenhagen out-patient clinic, community sample
Key inclusion criteria (11 listed)
- Informed and written consent.
- Clinically diagnosed diabetes mellitus type 2 for at least 5 years (diagnosed according to criteria of World Health Organization (WHO)).
- HbA1c >53 mmol/mol
- Stable medical treatment for at least 8 weeks.
- Plasma haemoglobin ≥8.00 mmol/L (male) or ≥6.4 mmol/L (female).
Key exclusion criteria (20 listed)
- Body mass index (BMI) <23 kg/m2
- Receipt of any investigational medicinal product within 3 months before screening in this trial.
- Inability to perform neuropsychological tests (e.g., visual impairment or auditory impairment, or language barrier).
- Participants with mental incapacity or language barriers precluding adequate understanding or co-operation or who, in the opinion of the investigator or their general practitioner, should not participate in the trial.
- Prior or contemporary use of any kind of hypnotica within 6 months, former p.n. use of melatonin is judged by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Melatonin oscillations (amplitude, peak, mesor, phase, period length (TAU))
Time frame: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Blood samples
Cortisol oscillations (amplitude, peak, mesor, phase, period length (TAU))
Time frame: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Blood samples
20 secondary outcomes
Dim light melatonin onset
Time frame: 24-hour in-hospital day, blood samples taken every hour from 18:00 until 00:00 (7 timepoints in total)
Phase angle (time between dim light melatonin onset and sleep)
Time frame: 24-hour in-hospital day, blood samples taken every hour from 18:00 until 00:00 (7 timepoints in total)
Cortisol awakening response
Time frame: 24-hour in-hospital day, blood samples taken at wake up, and 15-, 30-, and 60-minutes post-wake up
Diary on sleeping habits
Time frame: 30 days
Diary on eating window
Time frame: 30 days
Glycaemic variability
Time frame: 10-14 days
Sleep and waking states
Time frame: 10-14 days
Heart rate variability (fluctuations in time intervals between adjacent heart beats)
Time frame: 24-hour in-hospital day
Sleep architecture
Time frame: 24-hour in-hospital day
Cognition (verbal memory)
Time frame: 24-hour in-hospital day
Cognition (psychomotor speed and executive function)
Time frame: 24-hour in-hospital day
Cognition (executive function)
Time frame: 24-hour in-hospital day
Cognition (sustained attention)
Time frame: 24-hour in-hospital day
Cognition (verbal IQ)
Time frame: 24-hour in-hospital day
Insulin oscillations (amplitude, peak, mesor, phase, period length (TAU))
Time frame: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
C-peptide oscillations (amplitude, peak, mesor, phase, period length (TAU))
Time frame: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
TSH oscillations (amplitude, peak, mesor, phase, period length (TAU))
Time frame: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Glucose oscillations (amplitude, peak, mesor, phase, period length (TAU))
Time frame: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Glucagon oscillations (amplitude, peak, mesor, phase, period length (TAU))
Time frame: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Glucagon-like peptide-1 (GLP-1) oscillations (amplitude, peak, mesor, phase, period length (TAU))
Time frame: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jørgen Rungby, MD, DMSc principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Circadian Rhythm, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helena Z Wodschow, MD (+45 30313426, helena.zander.wodschow.03@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melatonin oscillations (amplitude, peak, mesor, phase, period length (TAU)) (time frame: 24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.